A Phase 3 interventional study of Tens therapy and Dapoxetine placebo in Premature Ejaculation, Sex Disorder and TEN, sponsored by Boston Medical Group. Recruiting at 1 site in Mexico. Open to male participants aged 18 Years to 62 Years. Per ClinicalTrials.gov, last updated 2024-05-22.
Sponsored by Boston Medical Group · Phase 3, Interventional, and Treatment
The objective of this clinical trial is to evaluate the effectiveness and safety of transcutaneous posterior tibial nerve stimulation therapy in patients with premature ejaculation. The main question to answer is:
Can the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve alone and combined with standard pharmacological treatment be evaluated in men with lifelong premature ejaculation, compared to standard pharmacological treatment with dapoxetine?
Patients will:
Be randomized in acontrolled clinical trial. Patients with a diagnosis of premature ejaculation who attend Boston Medical Group clinics in Mexico City will be included.
Be assigned by randomization to one of three treatment groups:
106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.
This study's planned enrollment of 129 is above the median of 84 across 89 interventional studies indexed under Premature Ejaculation.
Browse Premature Ejaculation studies →Boston Medical Group is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
There will be 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance. TENT therapy will be performed as follows: 1. The active electrode is placed and adhered 3 - 5 cm above the internal malleolus and 1 cm behind the tibia. The second reference electrode is attached to the calcaneus. Continuous current, Frequency: 20 Hz Pulse width: 200 µsec, Time: 30 min. Intensity: to the patient's tolerance, gross motor perception to verify correct application, upon reaching it, increase the intensity to clearly sensory activation. They will also receive dapoxetine placebo (capsules with only excipients without active ingredient) as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention.
Device: Tens therapy · Drug: Dapoxetine placebo
Patients in this group will receive dapoxetine 30 mg, taken 3 to 4 hours before sexual intercourse, for the 12 weeks of the study. In addition to the medication, patients will receive three weekly sessions of placebo therapy for twelve continuous weeks, lasting 30 minutes each. For this, the black electrode will be placed on the external malleolus and the red one 4 finger widths towards the head on the lateral edge of the tibia. 20 Hertz with a pulse width of 200 µsec will be administered in each session.
Drug: Standard treatment (dapoxetine 30 mg as needed) · Device: Placebo therapy
Tens therapy + standard treatment (dapoxetine 30 mg as needed). Patients in this group will receive electrostimulation therapy of the posterior tibial nerve, 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance. In addition to the therapy, patients in this group will receive dapoxetine as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention.
Device: Tens therapy · Drug: Standard treatment (dapoxetine 30 mg as needed)
There will be 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance. TENT therapy will be performed as follows: 1. The active electrode (cathode - red) is placed and adhered 3 - 5 cm above the internal malleolus and 1 cm behind the tibia. The second reference electrode (anode - black) is attached to the calcaneus. The equipment must previously be programmed under the following parameters: Continuous current Frequency: 20 Hz. Pulse width: 200 µsec Time: 30 min. Intensity: to the patient's tolerance, gross motor perception to verify correct application, upon reaching it, increase the intensity to clearly sensory activation.
Patients in this group will receive dapoxetine placebo (capsules with only excipients without active ingredient) as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention.
Patients in this group will receive dapoxetine 30 mg, taken 3 to 4 hours before sexual intercourse, for the 12 weeks of the study
In addition to the medication, patients will receive three weekly sessions of placebo therapy for twelve continuous weeks, lasting 30 minutes each. For this, the black electrode will be placed on the external malleolus and the red one 4 finger widths towards the head on the lateral edge of the tibia. 20 Hertz with a pulse width of 200 µsec will be administered in each session.
Change in intravaginal latency time
Average change in intravaginal latency time, measured with a stopwatch by the couple.
Time frame: 12 weeks
Change in intravaginal latency time
Average change in intravaginal latency time, measured with a stopwatch by the couple.
Time frame: 24 weeks
Clinical improvement in premature ejaculation
Proportion of patients with clinical improvement in premature ejaculation, defined as a three-fold increase in the intravaginal ejaculatory latency time.
Time frame: At weeks 12 (end of therapy) and 24 (three months of follow-up).
Change in the diagnosis of premature ejaculation
Proportion of patients with a change in the diagnosis of premature ejaculation according to the PEDT (Premature Ejaculation Diagnostic Tool) questionnaire score in the intervention groups
Time frame: At weeks 12 and 24 (greater than 12 to less than 12).
Global Impression of Change Scale
Global Impression of Change Scale score
Time frame: Weeks 12 and 24.
PEP (Premature Ejaculation Profile) questionnaire score
Change in the PEP (Premature Ejaculation Profile) questionnaire score
Time frame: At weeks 12 and 24
Adverse events
Type, frequency and severity of adverse events during therapy.
Time frame: 24 weeks
Plan to share: No
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